AstraZeneca US Covid-19 vaccine trial in US likely in late January, health official says

AstraZeneca will likely get the results of its U.S. Covid-19 vaccine trial in late January and could potentially seek emergency clearance, the U.S. government’s chief advisor to the Operation Warp Speed ​​program said on Wednesday.

The British drugmaker and the University of Oxford previously published interim efficacy results from their UK trial in November, but the results have raised questions among scientists.

The company said the vaccine could be 90% effective when given in a half dose followed by a full dose, based on a relatively small number of volunteers, while the overall effectiveness was about 70%.

Speaking at a meeting of the US Department of Health and Human Services, OWS chief adviser Moncef Slaoui said the large contrasting data set from trials in the UK and Brazil may not be sufficient to ensure that the vaccine receives emergency use clearance from the United States Food and Drug Administration. .

“Unless there is a very clear, facts and data based explanation of what is behind those two numbers (on efficiency), it is very likely that the package is not enough for the job.” ‘approval (FDA), ”he said.

AstraZeneca resumed its US trial in October after halting the study on September 6 after a report of severe neurological disease in a participant in the UK.

“I still expect that somewhere in January maybe, more towards the second half of January, the data will become available and potentially an emergency use authorization could be filed,” Slaoui said, referring at the American trial.